Circular stapler introducer with rigid cap assembly configured for easy removal

ABSTRACT

Introducers for introducing a surgical circular stapler into a patient. Various embodiments comprise a hollow flexible sheath that has a distal end and an open proximal end that is sized to receive a stapling head portion of the circular stapler therein. A rigid cap assembly may be attached to the distal end of the hollow flexible sheath The rigid cap assembly may be configured to selectively move between a closed position wherein a distal face of the stapling head is covered and an open position wherein the distal face of the stapling head is exposed. A portion of the rigid cap assembly has a shape that substantially matches a perimetrical shape of a portion of the stapling head to enable the rigid cap assembly to pass proximally over the stapling head when the introducer is withdrawn from the patient.

FIELD OF THE INVENTION

The present invention generally relates to surgical staplers, and moreparticularly, to devices and methods for introducing a circular staplingdevice into the colon of a patient.

BACKGROUND

In certain types of surgical procedures, the use of surgical staples hasbecome the preferred method of joining tissue and, as such, speciallyconfigured surgical staplers have been developed for these applications.For example, intra-luminal or circular staplers have been developed foruse in surgical procedures involving the lower colon wherein sections ofthe lower colon are joined together after a diseased portion has beenexcised. Circular staplers useful for performing such procedures aredisclosed, for example, in U.S. Pat. Nos. 5,104,025; 5,205,459;5,285,945; and 5,309,927 which are each herein incorporated by referencein their respective entireties.

In general, a conventional circular stapler typically consists of anelongated shaft that has a proximal actuating mechanism and a distalstapling mechanism mounted to the elongated shaft. The distal staplingmechanism commonly consists of a fixed stapling cartridge that containsa plurality of staples configured in a concentric circular array. Around cutting knife is concentrically mounted in the cartridge interiorto the staples for axial travel therein. Extending axially from thecenter of the cartridge is a movable trocar shaft that is adapted tohave a staple anvil removably coupled thereto. The anvil is configuredto form the ends of the staples as they are driven into it. The distancebetween a distal face of the staple cartridge and the staple anvil iscommonly controlled by an adjustment mechanism that is mounted to theproximal end of the stapler shaft for controlling the axial movement ofthe trocar. Tissue that is clamped between the staple cartridge and thestaple anvil is simultaneously stapled and cut when the actuatingmechanism is activated by the surgeon.

When performing a lower colon procedure using a circular stapler, theintestine is typically stapled using a conventional surgical staplerwith double rows of staples being emplaced on either side of thediseased portion of intestine to be removed. The target section issimultaneously cut as the adjoining end is stapled. After removing thediseased portion, the surgeon typically inserts the anvil into theproximal end of the lumen, proximal of the staple line. This is done byinserting the anvil head into an entry port cut into the proximal lumenby the surgeon. On occasion, the anvil can be placed transanally, byplacing the anvil head on the distal end of the stapler and insertingthe instrument through the rectum. The surgeon then ties the proximalend of the intestine to the anvil shaft using a suture or otherconventional tying device. Next, the surgeon cuts excess tissue adjacentto the tie and the surgeon attaches the anvil to the trocar shaft of thestapler. The surgeon then closes the gap between the anvil andcartridge, thereby clamping the proximal and distal ends of theintestine in the gap. The surgeon next actuates the stapler causingseveral rows of staples to be driven through both ends of the intestineand formed, thereby joining the ends and forming a tubular pathway.Simultaneously, as the staples are driven and formed, the concentriccircular knife blade is driven through the intestinal tissue ends,cutting the ends adjacent to the inner row of staples. The surgeon thenwithdraws the stapler from the intestine and the procedure is complete.

During such lower colon procedures, it may be difficult to insert thesurgical stapler thru the anus and past the transverse folds in therectal wall that protrude into the colon which are commonly referred toas the “Valves of Houston” and subsequently manipulated to the desiredarea. This problem is exacerbated when the stapler must be insertedwithout the anvil in position. In particular, the forward or distal endof most circular staplers comprises a relatively abrupt circular-shapedmember designed to support a circular staple cartridge. Suchblunt/abrupt shape makes it difficult to advance the forward end of thestapler past the Valves of Houston and other tissue.

Thus, the need exists for devices and methods for easily inserting asurgical stapler through a patient's anus into the lower colon or intoother areas within the patient.

The foregoing discussion is intended only to illustrate some of theshortcomings present in the field of the invention at the time, andshould not be taken as a disavowal of claim scope.

BRIEF SUMMARY

In connection with a general aspect of the present invention, there isprovided an introducer for introducing a surgical circular stapler thathas a handle portion, an elongated shaft that protrudes from the handleportion, and a stapling head that is coupled to the elongated shaft intoa patient. In connection with various embodiments, the introducercomprises a hollow flexible sheath that has a distal end and an openproximal end. The hollow flexible sheath may be sized to receive thestapling head and at least a portion of the elongated shaft therein. Arigid cap assembly may be attached to the distal end of the hollowflexible sheath. The rigid cap assembly may be configured to selectivelymove between a closed position wherein a distal face of the staplinghead is covered by the rigid cap assembly when the stapling head hasbeen inserted therein to a fully inserted position and an open positionwherein the cap assembly may be proximally withdrawn from around thestapling head and elongated shaft. The cap assembly may have a portionthat is shaped to match a shape of a perimeter of a correspondingportion of the stapling head to enable the rigid cap assembly to passproximally past the stapling head when being withdrawn therefrom.

In connection with another general aspect of the present invention,there is provided an introducer for introducing a surgical circularstapler that has a handle portion, an elongated shaft that protrudesfrom the handle portion, and a stapling head that is coupled to theelongated shaft into a patient. In connection with various embodimentsthe introducer comprises a hollow flexible sheath that has a distal endand an open proximal end. The hollow flexible sheath may be sized toreceive the stapling head and at least a portion of the elongated shafttherein. A radially-openable barrel member may be attached to a distalend of the hollow flexible sheath that defines an opening for receivingthe stapling head therein. A latch member may be oriented in engagementwith a pair of opposed ends of the radially-openable barrel member. Thelatch member may be selectively movable from a latched position whereinthe latch member engages the opposed ends of the barrel member and anunlatched position wherein the opposed ends may move radially away fromeach other. A rigid cap member may be hingably attached to theradially-openable barrel member and may be movable between a closedposition wherein the rigid cap member is retained in a closed positioncovering a distal end of the opening in the barrel member and an openposition wherein the rigid cap member is movable to a position exposingthe distal end of the opening. The rigid cap member may have anunderside that has a shape that matches a shape of a perimeter of acorresponding portion of the stapling head to enable the rigid capmember to pass proximally past the stapling head when being proximallywithdrawn therefrom.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention,and, together with the general description of the invention given above,and the detailed description of the embodiments given below, serve toexplain the principles of the present invention.

FIG. 1 is a perspective view of a surgical circular stapling instrument;

FIG. 2 is another perspective view of the circular surgical staplinginstrument of FIG. 1 prior to the installation of an introducerembodiment of the present invention thereon;

FIG. 3 is a side elevational view of an introducer embodiment of thepresent invention;

FIG. 4 is a top view of the introducer of FIG. 2;

FIG. 5 is a top view of the introducer of FIGS. 3 and 4;

FIG. 6 is another top view of the introducer of FIGS. 2-5 with the coverpanel removed from the handle assembly;

FIG. 7 is a partial perspective view of an introducer embodiment of thepresent invention installed on a circular stapling instrument;

FIG. 8 is a partial side elevation view of the introducer and circularstapler of FIG. 7;

FIG. 9 is a partial top view of the introducer and circular stapler ofFIGS. 7 and 8;

FIG. 10 is an elevational view of a cap assembly embodiment of thepresent invention;

FIG. 11 is another elevational view of the cap assembly of FIG. 10 withthe release latch removed therefrom;

FIG. 12 is a perspective view of the cap assembly of FIGS. 8-11 with therelease latch removed therefrom and the cap disengaged from the barrelassembly;

FIG. 13 is a cross-sectional view of a cap assembly embodiment of thepresent invention with the cap engaged with the barrel assembly;

FIG. 14 is a partial side elevational view of a portion of a circularstapler and a cap of an introducer embodiment of the present invention;

FIG. 14A is another partial side elevational view of the circularstapler and cap with the cap sliding off the perimeter of the staplinghead portion of the circular stapler;

FIG. 15 is a top view of a cap assembly embodiment of the presentinvention with the cap in an open position;

FIG. 16 is another top view of the cap assembly embodiment of FIG. 15with a line illustrating a low profile cap embodiment;

FIG. 17 is a side elevational view of the cap assembly embodiment ofFIGS. 15 and 16;

FIG. 18 is a top perspective view of a cap assembly embodiment of thepresent invention;

FIG. 19 is a bottom view of the cap assembly of FIG. 18;

FIG. 20 is a top perspective view of another cap assembly embodiment ofthe present invention;

FIG. 21 is a bottom view of the cap assembly of FIG. 20;

FIG. 22 is a perspective view of a circular surgical stapling instrumentprior to the installation of another introducer embodiment of thepresent invention thereon;

FIG. 23 is a perspective view of a circular surgical stapling instrumentprior to the installation of another introducer embodiment of thepresent invention thereon;

FIG. 24 is an exploded elevational view illustrating another introducerembodiment of the present invention prior to installation on a portionof a stapling head of a circular stapler;

FIG. 25 is a cross-sectional view of the introducer of FIG. 24 installedon a stapling head of a circular stapler;

FIG. 26 is a distal end view of an introducer embodiment of the presentinvention;

FIG. 27 is a distal end view of another introducer embodiment of thepresent invention;

FIG. 28 is a distal end view of another introducer embodiment of thepresent invention;

FIG. 29 is a cross-sectional view of another introducer embodiment ofthe present invention installed on a stapling head of a circularstapler;

FIG. 30 is a side elevational view of another introducer embodiment ofthe present invention in a closed position;

FIG. 31 is another side elevational view of the introducer of FIG. 31;

FIG. 32 is another side elevational view of the introducer of FIGS. 30and 31 in a closed position;

FIG. 33 is a distal end view of another introducer embodiment of thepresent invention attached to the stapling head of a circular stapler;

FIG. 34 is a side elevational view of another introducer embodiment ofthe present invention attached to the stapling head of a circularstapler with the trocar portion of the circular stapler in an extendedposition;

FIG. 35 is a distal end view of another introducer embodiment of thepresent invention attached to the stapling head of a circular stapler;

FIG. 36 is a side elevational view of another introducer embodiment ofthe present invention attached to the stapling head of a circularstapler with the trocar portion of the circular stapler in an extendedposition;

FIG. 37 is another side elevational view of the introducer and staplinghead of FIG. 36 with the trocar portion of the circular stapler in awithdrawn position;

FIG. 38 is a side elevational view of another introducer embodiment ofthe present invention attached to a stapling head of a circular stapler;

FIG. 39 is a partial perspective view of another introducer embodimentof the present invention attached to the stapling head of a circularstapler;

FIG. 40 is another partial perspective view of the introducer embodimentof FIG. 39 being unwound from the stapling head of the circular stapler;

FIG. 41 is a partial perspective view of another introducer embodimentof the present invention attached to the stapling head of a circularstapler;

FIG. 42 is a partial perspective view of another introducer embodimentof the present invention attached to the stapling head of a circularstapler;

FIG. 43 is another partial perspective view of the introducer of FIG. 42being withdrawn proximally from the stapling head of the circularstapler;

FIG. 44 is a partial perspective view of another introducer embodimentof the present invention attached to the stapling head of a circularstapler;

FIG. 45 is another partial perspective view of the introducer embodimentof FIG. 44 wherein a release motion has been initially applied thereto;and

FIG. 46 is another partial perspective view of the introducer of FIGS.44 and 45 illustrating further application of the release motionthereto.

DETAILED DESCRIPTION

The Applicant of the present application also owns the U.S. PatentApplications identified below which were filed on even date herewith andwhich are each herein incorporated by reference in their respectiveentirety:

U.S. patent application Ser. No. 12/621,672, entitled “DEVICES ANDMETHODS FOR INTRODUCING A SURGICAL CIRCULAR STAPLING INSTRUMENT INTO APATIENT”;

U. S. patent application Ser. No. 12/621,683, entitled “CIRCULAR STAPLERINTRODUCER WITH RADIALLY-OPENABLE DISTAL END PORTION”;

U. S. patent application Ser. No. 12/621,688, entitled “CIRCULAR STAPLERINTRODUCER WITH RIGID DISTAL END PORTION”; and

U.S. patent application Ser. No. 12/621,667, entitled “CIRCULAR STAPLERINTRODUCER WITH MULTI-LUMEN SHEATH”.

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the various embodiments of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical”, “horizontal”, “up”, and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

FIG. 1 illustrates a conventional circular stapler 10. The constructionand operation of such circular staplers are generally known in the art.Thus, the specific components and features of such circular stapler willnot be discussed in detail herein beyond what may be necessary tounderstand the construction and operation of the various embodiments ofthe present invention. As the present Detailed Description proceeds,those of ordinary skill in the art will understand that the variousembodiments of the present invention may be effectively employed with avariety of different circular stapler configurations without departingfrom the spirit and scope of the present invention. Accordingly, thescope of protection afforded to the various embodiments of the presentinvention should not otherwise be limited to use with the exemplarycircular stapler depicted herein.

As can be seen in FIG. 1, a conventional circular stapler 10 generallyincludes a handle portion 12 that has an elongated shaft 14 protrudingtherefrom. A stapling head 16 is coupled to the distal end 15 of theelongated shaft 14 and is configured to operably support a staplecartridge 17 and movable knife assembly (not shown) therein. Thecircular stapler 10 further includes an anvil 20 that has an anvil body22. The anvil 20 has an anvil shaft 24 that is configured to beremovably attached to a trocar (not shown) that is movably supportedwithin the elongated shaft 14 of the circular stapler 10. Movement ofthe trocar is achieved by rotating an adjustment knob 18 that is locatedat the proximal end of the handle portion 12. An indicator panel 19 maybe provided on the handle portion 12 to provide the user with anindication of the position of the body portion 22 of the anvil 20relative to the staple cartridge 17. Thus, when the anvil shaft 24 isattached to the movable trocar, the position of the anvil body 22relative to the staple cartridge 17 in the stapling head assembly 16 maybe adjusted by rotating the adjustment knob 18. The stapling head 16further supports a staple driver assembly (not shown), the operation ofwhich is controlled by a trigger assembly 26 on the handle portion 12.Further details concerning the operation and assembly of the exemplarycircular stapler 10, for example, may be gleaned from reference to U.S.patent application Ser. No. 12/408,905, filed Mar. 23, 2009, entitled“Circular Surgical Stapling Instrument With Anvil Locking System” toJohn P. Measamer, the disclosure of which is herein incorporated byreference in its entirety.

FIGS. 2-6 illustrate a circular stapler introducer 100 of the presentinvention that may be used in connection with a circular stapler 10. Invarious embodiments, the introducer 100 comprises an elongated hollowflexible sheath 110 that may be fabricated from, for example, a plasticmaterial such as polyurethane blends, polyesters, polyethylene orpolypropylene having a thickness of 0.004-0.015 inches and forms a firstlumen 29 sized to be readily inserted over the elongated shaft 14 of acircular stapler 10. The sheath 110 has a distal end 114 and an openproximal end 112 as well as a top portion generally designated as 111and a bottom portion 113. See FIG. 3. A handle assembly 130 may beattached to the open proximal end 112 by, for example, adhesive orultrasonic welding, radio frequency (RF) welding or heat staking. Thedistal end 114 of the sheath 110 may be attached to a rigid cap assembly130 by adhesive or by ultrasonic welding, radio frequency (RF) weldingor heat staking. In various embodiments, a “weakened region” in the formof, for example, a perforated seam 116 may extend along the bottomportion 113 of the sheath 110 from the open proximal end 112 to thedistal end 114. In addition, a second lumen 120 may be formed in thewall of the sheath 110 and extend from the open proximal end 112 to thedistal end 114. In particular, the second lumen 120 may helically extendfrom the top portion 111 of the proximal end 112 to the bottom portion113 at the distal end 114. The second lumen 120 may accommodate arelease member 122 that extends from the handle assembly 130 to a latchmember 140 that is movably supported in a distal end portion of thesecond lumen 120. In various embodiments, the release member 122 maycomprise, for example, a suture. In other embodiments, the releasemember 122 may comprise a relatively thin flexible bar or similar memberfor transmitting a release motion to the latch member 140 attachedthereto. The second lumen 120 may be formed in the wall of the sheath110 by, for example, sewing, ultrasonic welding, radio frequency (RF)welding, heat staking, etc. The release member 122 and the latch member140 may collectively form a release arrangement, generally designated as121. See FIG. 10.

FIGS. 10-19, depict a rigid cap assembly 150 that may be used inconnection with various embodiments of the present invention. The rigidcap assembly 150 may have a barrel member 152 that is attached to thedistal end 114 of the sheath 110. The barrel member 152 comprises apartial ring-like member that has two opposed ends 154, 156. A rigid capmember 160 is “hingably attached” to the barrel member 152 by a tether162. See FIG. 17. In various embodiments, the rigid cap assembly 150 ismanufactured as a single injection molded piece that has significantlydifferent physical properties. In various embodiments, for example, therigid cap assembly 150 may be injection molded from polyurethane blends,polyesters, polyethylene or polypropylene.

As will be discussed in further detail below, the cap member 160 is maderigid by increasing its cross-sectional area while the tether 162 andbarrel member 152 are preferably designed to allow significantdeflection in specific directions by reducing their respectivecross-sections. The cap member 160 has a relatively blunt distal surface164 that is substantially smooth to minimize the force required toinsert the introducer 100 and the portions of the circular stapler 10housed therein through the patient's sphincter as well as to facilitatenavigation of the device through the Valves of Houston and otheranatomy. The underside 166 of the cap member 160 may have a series ofreinforcing ribs 168 formed therein to increase its cross-sectional areaand make the cap member 160 substantially rigid. See FIGS. 13 and 19.

In various embodiments, the underside 166 of the cap member has a shapethat substantially matches the shape of a portion of the perimeter ofthe stapling head 16. More specifically and as can be seen in FIG. 13,the underside 166, which is formed by reinforcing ribs 168, is arcuatein shape which matches a portion of the circular perimetrical shape ofthe stapling head 16 of the circular stapler 10. As can be further seenin FIG. 14, the cap member 160 has sides 170, 172 each has a cutout wallportion 174 that corresponds with the arcuate underside 166. Sucharcuate underside 166 and cutout wall portions 174 enable the capassembly 150 to pass proximally off the stapling head 16 when beingproximally withdrawn over the circular stapler 10 to thereby reduce theradial distention of the bowel when the cap assembly 150 passes by thestapling head 16 of the circular stapler 10. For example, FIG. 16provides an illustrative comparison between a cap assembly 150 with noarcuate underside 166 (represented by dotted line 180) and the capassembly 150 with an arcuate underside 166. As illustrated, for oneexemplary embodiment, the cap assembly without the arcuate underside hasa 0.22″ higher profile and would therefore further distend the bowel asit is withdrawn proximally over the stapling head 16.

In various embodiments, the tether 162 may be designed to be longer thanthe distance required to connect the cap member 160 to the barrel member152 in the closed position (FIG. 10). That is, the tether 162 may coilinside the cap assembly 150 when the rigid cap portion 160 is retainedin the closed position. Such arrangement permits the cap member 160 tofollow a substantially curved path while passing over the corner of thestapling head 16 of the stapler 10 and to move independently from thebarrel member 152 during removal. See FIGS. 14 and 14A. In oneembodiment, the tether 162 is diametrically opposite from the locationwherein the latch member 140 engages the opposed ends 154, 156 of thebarrel member 152. See FIGS. 18 and 19. In an alternative embodiment,the tether 162 is located 90 degrees from the latch 140 member. SeeFIGS. 20 and 21.

Various embodiments of the cap assembly 150 employ features which worktogether to ensure that the cap member 160 does not open during theinsertion process while retaining the ability to be easily opened andremoved at the appropriate time. For example, as can be seen in FIG. 13,various embodiments of the cap assembly 150 may include aninwardly-extending retainer flange 190 that is formed on portions of thebarrel member 152. The retainer flange 190 may be positioned toretainingly engage corresponding retention ribs 167 formed on the lowerrim of the cap member 160. As can be seen in FIG. 13, a series ofgussets 194 may be formed with the retainer flange 190 to furtherstabilize and rigidify the retention flange 190. Various cap memberembodiments may include at least one retention rib on the cap member 160to retainingly secure the cap member 160 in a closed position whereinthe cap member 160 covers the distal face 25 of the stapling head 16(FIG. 10). In various embodiments, a series of three ribs 200, 202, 204may be formed on the two portions of the cap member 160 that are betweenthe tether 162 and the arcuate cut out portions 174. The two outer ribs200, 202, 204 may be provided with chamfered lead-out portions 206. SeeFIG. 12. Such chamfered lead out portions 206 interface with theretention flange 190 on the barrel member 152 and may serve to minimizethe chances of the cap member 160 binding on the retention flange 190during the unlatching process without significantly jeopardizing theability of the rib 167 and retention flange 190 arrangement to carryloads during the insertion process.

As can be seen in FIGS. 11 and 12, the opposed ends 154, 156 of thebarrel member 152 are spaced from each other to define a latch region210 for receiving the latch member 140 therein. The latch member 140 maybe formed from a plastic material and have a body portion 141 that has apair of distally protruding latch tabs 142, 144 formed thereon. See FIG.11. The latch tabs 142, 144 are sized to extend into latch cavities 157,159 formed in the opposing ends 154, 156 of the bar 152. See FIGS. 10and 11. Thus, when the latch tabs 142, 144 are received in the latchcavities 157, 159, the barrel member 152 forms a radially-openablering-like structure sized to accommodate the stapling head 16 of thecircular stapler 10 therein. In various embodiments, when the barrelmember 152 is latched in the closed position wherein the cap member 160covers the distal face 25 of the stapling head 16 of the circularstapler 10, the cap member 160 may sit directly on the distal face 25 ofthe stapling head 16 of the circular stapler 10 without interfering withany of the staple pockets in the staple cartridge 17 support therein.Such arrangement permits the forces experienced by the cap member 160during the insertion process to be transmitted directly to the staplinghead 16 of the circular stapler 10 without the need for any forcebalancing or intermediate components.

Also in various embodiments, the release member 140 may be furtherformed with a release finger 145 that may serve to assist with radiallyopening the barrel member 152 when the latch member 140 is pulledproximally out of engagement with the opposed ends 154, 156 of thebarrel member 152. More specifically and with reference to FIG. 11, thelatch member 140 may be formed with a release finger 145 that iscentrally disposed between the latch tabs 142, 144. The release finger145 may be formed with cam portions 147 that are designed to engage camsurfaces 161, 163 formed on the opposed ends 154, 156 of the barrelmember 152 such that, as the latch member 140 is pulled in the proximaldirection “P”, the cam portions 147 engage the cam surfaces 161, 163 tourge the opposed ends 154, 156 of the barrel member 152 radially apartfrom each other (represented by arrows “R”, in FIG. 12.). Thus the latchmember 140 is pulled in a direction (proximal direction “P”) that issubstantially perpendicular to the direction of motion “R” required todisengage the cap member 160 from the barrel member 152. When the latchmember 140 is removed and the clinician continues to apply an additionalwithdrawal motion to the introducer 100, the opposed ends 154, 156 ofthe barrel member 152 are permitted to further radially separate andenable the cap member 160 to disengage from the barrel member 152 andmove to an open position. In doing so, the cap member 160 may bepermitted to rotate to a lateral open position to facilitate proximalmovement of the cap assembly 150 over the stapling head 16 as theintroducer 100 is withdrawn proximally from the patient. See FIG. 14.

As can be seen in FIGS. 7-9, the handle assembly 130 may be designed toconform to the geometry of the handle portion 12 of the circular stapler10 when the stapling head 16 has been inserted into the closed capassembly 150 in a fully inserted position. For example, when a lower rimportion of the rigid cap member 160 is in contact with the distal face25 of the stapling head 16, the stapling head 16 may be considered to bein the “fully inserted” position. More broadly, the circular stapler 10may be considered to be in a fully inserted position when the distalface 25 is in contact with a portion of the rigid cap member 160.

In various embodiments, the handle assembly 130 may be configured insuch a way as to prevent improper installation of the introducer 100 onthe circular stapler 10. For example, the handle assembly 130 may be“orientation-specific” such that it includes features which mate withcorresponding surfaces on the handle portion 12 of the circular stapler10 when the stapling head has been inserted to the fully insertedposition, while at the same time interfering with other surfaces if theintroducer 100 is installed incorrectly. In addition, many circularstaplers 10 include an indicator panel 19 that is located on the upperside of the handle portion. See FIG. 1. Such indicator panel 19 may, forexample, provide the clinician with an indication of the position of theanvil 20 relative to the stapling head 16. In various embodiments, thehandle portion 130 of the introducer 100 may be designed to cover orobscure the indicator panel 19 of the circular stapler 10. Sucharrangement serves to ensure that the user is aware that the introducer100 is installed on the stapler 10 and thereby prevents the user fromattempting to fire the circular stapler 10 without first removing theintroducer 100. For example, the handle assembly 130 includes a forwardportion 220 that covers or otherwise obscures the indication panel 19 ofthe circular stapler 10.

In various embodiments, the proximal end 124 of the release member 122or suture is attached to a release slider 230. As can be seen in FIG. 6,the suture 122 may be attached to a forward tab portion 232 of therelease slider 230 that is sized to be slidably received within a cavity222 formed in the forward portion of the handle assembly 130. Theforward tab portion 232 is slidably retained within the cavity 222 by acover 240 that may be attached to the handle assembly 130 by a series ofretainer tabs 242 that are oriented to snappingly engage correspondingsnap cavities 224 in the handle assembly 130. See FIGS. 5 and 6

Various embodiments of the present invention may also incorporate ameans for multiplying a proximal travel distance of the suture 122relative to a distance that the release slider 230 is moved on thehandle portion 12 of the circular stapler 10. For example, variousembodiments may employ a pulley-type arrangement 250 to multiply thetravel distance of the suture 122 relative the distance that the releaseslider 230 is moved in the proximal direction “P”. Such arrangement mayallow for greater travel to ensure the release of the cap member 160without the need to lengthen the handle portion 130. For example, asshown in FIG. 6, the proximal end portion 124 of the suture 122 extendsthrough a slot 252 in the handle assembly 130 and loops through a hole234 in the forward slider tab 232. The end 124 of the suture 122 maythen be attached to a fixed post 254 on the handle assembly 130

To facilitate easy removal of the introducer 100, the release slider 230may be provided with a relatively “low profile” to enable the clinicianto maintain a grip on the handle portion 12 of the stapler 10 withoutsignificantly changing their grip or method from what they would do withthe circular stapler 10 alone. See FIGS. 7-9. Also, in variousembodiments, the release slider 230 may be provided with a hole 236and/or two lateral wing portions 238. Thus, this arrangement allows theclinician to apply force to the release slider 230 in the proximaldirection “P” using either a single finger in the hole 236 or twofingers on the lateral wing portions 238.

As can also be seen in FIG. 6, the forward portion 220 of the handleassembly 130 may also be provided with stops 229 that are arranged toengage forward tabs 239 formed on the forward tab portion 232 of therelease slider 230. Thus, in use, once the circular stapler 10 has beeninserted into the introducer 100 to the fully inserted position and thestapler 10 and introducer 100 have been inserted to a desired positionwithin the patient, the clinician may then pull the release slider 230in a proximal direction to apply an amount of tension or release motionto the suture 122 to draw the latch member 140 to an unlatched position.Further pulling on the release slider 230 will result in the forwardtabs 239 contacting the stops 229. Once the forward tabs 239 contact thestops 229, further pulling of the release slider 230 in the proximaldirection causes the entire introducer 100 to move in the proximaldirection. Such arrangement enables the entire introducer 100 to bedecoupled from the stapler 10 and withdrawn from the patient by movingthe release slider 230 in the proximal direction on the handle portion12 of the circular stapler 10. The removal of the introducer 100 fromthe stapler 10 may be accomplished without removing the stapler 10 fromthe patient.

To use the introducer 100, the clinician simply inserts the circularstapler 10 into the sheath 110 to the fully inserted position and alignsthe introducer 100 relative to the handle portion 12 such that theforward portion 220 of the handle portion 130 covers the indicationpanel 19 of the circular stapler 10. To aid in the insertion process,the stapling head 16 and shaft portion 14 of the circular stapler 10, aswell as the cap assembly 150 and sheath 110 of the introducer 100, maybe lubricated prior to commencing the insertion process. When thecircular stapler 10 has been properly inserted into the introducer 100,the rim of the cap 160 which is engaged with the flange 190 of thebarrel assembly 152 and thereby retained in the closed position asillustrated in FIGS. 3-6, 10 and 13, will rest on the stapling head 16of the stapler 10. The user then inserts the stapler 10 and introducer100 into a desired position in the colon. Once the stapler 10 is in adesired position, the clinician may pull on the release slider 230 inthe proximal direction “P” which causes the suture 122 to pull theretainer latch 140 out of engagement with the ends 154, 156 of thebarrel assembly 152. As the retainer latch 140 is drawn proximally, thecam surfaces 147 on the release finger 145 cooperate with the camsurfaces 161, 163 formed on the opposed ends 154, 156 of the barrelassembly 152 such that, as the release member 140 is pulled in theproximal direction “P”, the ends 154, 156 are urged radially apart.Further pulling of the release slider 230 results in the forward tabs232 contacting the stops 229 such that further pulling of the slider 230results in the entire introducer 100 being pulled proximally over thecircular stapler 10. Such pulling of the introducer 100 may cause thesheath 110 to separate along the line of perforations 116 and the cap160 to move to an open position (FIGS. 14 and 15) to thereby enable theintroducer 100 to be withdrawn from the patient prior to firing thestapler 10.

FIG. 22 illustrates another introducer 300 of the present invention. Inthis embodiment, the introducer 300 comprises a hollow sheath 302 thathas a closed end 304 and an open end 306 for insertion onto the circularstapler 10. The sheath 302 may be fabricated from a flexible materialsuch as from those materials commonly employed to fabricate condoms. Inone embodiment, the sheath 302 is fabricated from a single piece ofmaterial that has an elongate seam 310 that extends the length of thesheath 302. In particular, the sheath material is folded over such thatthe end 312 of the material overlaps end 314 of the material representedby distance “O” in FIG. 22. The ends 312, 314 are then stitched togetherby a suture 316 forming the seam 310. Thus, the sheath 302 is insertedover the stapling head 16 of the stapler 10 prior to insertion into thepatient. After the stapler 10 and sheath 302 have been inserted intoposition, the sheath 302 may be removed by pulling the suture 316 tothereby release the seam 310 to permit the sheath 302 to be removed. Inother embodiments, the sheath 302 is fabricated from two pieces offlexible material that are stitched together with two sutures 316 in themanner described above. To remove the sheath 302, the clinician simplypulls on one or both of the sutures 316.

FIG. 23 illustrates another introducer 320 of the present invention. Inthis embodiment, the introducer 320 comprises a hollow sheath 322 thathas a closed end 324 and an open end 326 for insertion onto the circularstapler 10. The sheath 322 may be fabricated from a flexible materialsuch as that material commonly employed to fabricate condoms. In oneembodiment, the sheath 320 has a closed end 342 and an open end 326 andis provided with at least one weakened area 328 which may comprise aperforated line or seam that extends the length of the sheath 322. Thus,the sheath 322 is inserted over the stapling head 16 of the stapler 10prior to insertion into the patient. After the stapler 10 has beeninserted into position, the sheath 322 may be removed by pulling on theweakened area 328 to permit the sheath 322 to be separated from thestapler 12.

FIGS. 24-28 illustrate another introducer 330 of the present invention.In this embodiment, the introducer 330 comprises a sheath 332 that has aclosed distal end 334 and an open proximal end 336 that is sized to bestretched over at least a distal portion of the stapling head 16 of thecircular stapler 10. The sheath 332 may be fabricated from, for example,silicone, latex or other relatively low durometer material (i.e., adurometer of 90 A). In various embodiments, acircumferentially-extending raised bumper area 338 may be formed aroundthe circumference of the closed distal end 334 as shown in FIGS. 24 and25. In some embodiments, a central portion 335 extends inwardly from thecircumferentially-extending bumper area 338 to enclose an open centralarea 27 in the stapling head 16. See FIG. 25.

As can also be seen in FIG. 25, the bumper area 338 extends distallybeyond (or in other words is “raised above”) a plane D-D defined by adistal face 25 of the stapling head 16. In some embodiments, the bumperarea 338 is formed from solid material. See FIG. 26. In otherembodiments, a circumferentially-extending hollow area 340 is formedtherein. In other embodiments, hollow area 340 comprises a plurality ofpockets 341. See FIG. 28. The area 340 and pockets 341 may be filledwith air or a liquid such as saline solution for example. In use, thesheath 332 is rolled over the stapling head 16 of the stapler 10. Thesheath 332 may be left in place while closing and firing the stapler 10in which case the area 340 or pockets 341 would be broken leaving onlythe sheath material behind under the staple crown inside the rectallumen.

FIG. 29 illustrates another introducer 350 of the present invention. Inthis embodiment, the introducer 350 comprises a sheath 352 that has adistal end 354 and an open proximal end 356 that is sized to bestretched over the stapling head 16 of the circular stapler 10. Thesheath 352 may be fabricated from, for example, silicone, latex or otherrelatively low durometer material (i.e., a durometer of 90 A). Invarious embodiments, a circumferentially-extending raised bumper area357 may be formed around the circumference of the sheath 352 such thatit covers the distal face 25 of the stapling head 16 and a portion 359extends into the central open area 27 and below the plane D-D defined bythe distal face 25. See FIG. 29. In some embodiments, the bumper area357 is formed from solid material. In other embodiments, acircumferentially-extending hollow area 358 is formed therein. Thehollow area 358 may be filled with air or a liquid such as salinesolution. In other embodiments, the circumferentially extending hollowarea 358 is segmented (e.g., comprises a series of discrete pockets thatextend around the circumference of the sheath 352). The discrete pocketsmay be filled with air or liquid such as saline solution for example. Inuse, the sheath 352 is rolled over the distal end portion of thestapling head 16. The sheath 352 may be left in place while closing andfiring the stapler 10 in which case the hollow area 358 or pockets wouldbe broken leaving only the sheath material behind under the staple crowninside the rectal lumen.

FIGS. 30-32 illustrate another introducer 360 of the present invention.In this embodiment, the introducer 350 comprises a cover 362 that issized to be installed on at least a distal portion of the stapling head16. In one embodiment, the cover 362 comprises a “C”-shaped body portion363 that may be fabricated from, for example, polyurethane blends,polyesters, polyethylene, polycarbonate or polypropylene and be sized tobe snapped onto the stapling head 16 and portion of the elongated shaft14 of the circular stapler 10. See FIG. 31. In various embodiments, thedistal end 364 of the body portion 363 has at least three normallyclosed fingers 366 that, when moved distally on the stapling head 16,close together forming, for example, a “tulip-like” shape for insertioninto the anus. See FIG. 30. The body portion 363 may have a retractionmember 370 formed thereon for facilitating the application of aretraction motion thereto. When the stapler 10 has reached its targetedinsertion point, the cover 362 may be pulled toward the handle portion12 of the stapler 10, thus pulling the fingers 366 to the vertical sidesof the stapling head 16 exposing the distal face 25 of the staplecartridge 17. See FIG. 32.

FIGS. 33 and 34 illustrate another introducer 380 of the presentinvention. In this embodiment, the introducer 380 comprises a cover 382that includes four fingers 384 that extend from a centrally disposed hub386 that has a trocar access hole 388 therethrough. The proximal end 390of each of the fingers 384 has a retention flange 392 formed thereonthat extend into the central opening 27 and engage the central wallportion 21 of the stapling head 16. To install the cover 382, the cover382 is positioned over the stapling head 16 as shown in FIGS. 33 and 34and the trocar 23 of the circular stapler 10 is advanced such that thedistal end portion 35 of the trocar 23 protrudes through the hole 388 inthe central hub 386. Once in position, the trocar 23 is retractedproximally into central opening 27 to thereby force the fingers 384 intoa generally bulbous, “mushroom-like” cross-sectional shape. Once thestapler 10 is positioned in the rectum, the trocar 23 can then bedeployed and pushed thru the rectal wall allowing access to theaccessory fingers 384 which can be removed from the trocar 23.

FIGS. 35-37 illustrate another introducer 400 of the present invention.In this embodiment, the introducer 400 comprises a cover 402 thatinclude four fingers 404 that are attached together by a sheath 410. SeeFIG. 35. The sheath may be made from, for example, silicone material.The apex area 412 of the sheath 410 may have a trocar access hole 414therethrough. The proximal end 406 of each of the fingers 404 has aretention flange 408 formed thereon that extend into the central opening21 in the stapling head 16. To install the cover 400, the cover 402 ispositioned over the stapling head 16 as shown in FIGS. 35 and 36 and thetrocar 23 of the circular stapler 10 is advanced distally such that thedistal end portion 35 of the trocar 23 protrudes through the hole 414 inthe sheath 410. Once in position, the trocar 23 is retracted to therebyforce the fingers 404 into a generally mushroom cross-sectional shape.See FIG. 37. Once the stapler 10 is positioned in the rectum, the trocar23 can then be deployed and pushed thru the rectal wall allowing accessto the accessory fingers 404 which can be removed from the trocar 23.

FIG. 38 illustrates another introducer 420 that may be fabricated from,for example, polyurethane blends, polyesters, polyethylene,polycarbonate or poly propylene that has at least four fingers 422 thatare interconnected at a hub or apex area 424. The proximal ends 426 ofthe fingers 422 snap onto the stapling head 16. In this embodiment, theintroducer 420 is designed to go up the colon and then be removed. Thisis unlike the introducer 400 described above wherein the trocar is inthe extended position to hold it in place until the device is inposition and then the trocar is brought proximally.

FIGS. 39 and 40 illustrate another introducer 500 that may be used inconnection with a circular stapler 10. As can be seen in those Figures,the introducer 500 may comprise a molded arrangement with perforationsand may be fabricated from, for example, polyurethane blends,polyesters, polyethylene or polypropylene or alternatively couldcomprise wound strip that is sewn together or held in place withoutcovering. The strip 504 may have a width of, for example, 0.250 inchesand a thickness of, for example, 0.020 inches. The strip 504 may form abase portion 506 sized to extend around the circumference of thestapling head 16. The base portion 506 may be sized relative to thestapling head 16 such that, when held together in close spiralrelationship, the spiral strip 504 forms a relatively tight(interference) fit with the stapling head 16 to retain the introducerthereon. The spirally wound strip 504 forms a plurality of successivepasses 508 that tapers to a blunt distal end 510. As can be seen in FIG.36, one embodiment resembles a blunt-ended “beehive-shape” thatsubstantially encloses or covers the distal face of the stapling head16. The spiral passes 508 may be held in substantial abuttingrelationship (i.e., spirally wound closed ended relationship) by aretainer member 510. In various embodiments, the retainer member 510 maycomprise a thin (e.g., 1 to 4 Mils) layer of shrink wrap that extendsover the introducer 500. The introducer 500 also includes a releasemember 520 that is attached to the strip material 504 such that uponapplication of a release motion thereto, the spiral wound strip member504 is unwound from engagement with the distal portion of the staplinghead 16. In one embodiment, for example, the release member comprises arelease suture 520 that is attached to the distal end 512 of the strip504. The release suture 520 may pass through a hole 522 in a portion ofthe strip 504 forming the base portion 506 and extend proximally out tothe handle portion of the stapler 10 to enable the release suture 520 tobe grasped by the clinician.

The introducer 500 may be installed by the supplier of the stapler 10 byshrink wrapping the introducer 500 to the stapling head 16. In use, theclinician inserts the stapler and introducer assembly 530 into thepatient's anus and past the Valves of Houston to the desired area. Oncethe clinician has determined that the stapler 10 is in the desiredposition, the clinician can then pull the release suture 520 in theproximal direction “P” which causes the shrink wrap 510 to rupturethereby permitting the introducer 500 to unwind as illustrated in FIG.40. Continued pulling on the release suture 520 will enable theintroducer 500 to be withdrawn from the patient.

FIGS. 41-43 illustrate another introducer 600 that may be used inconnection with a circular stapler 10. As can be seen in those Figures,the introducer 600 may have a base portion 602 sized to be retained onthe stapling head 16. The introducer 600 is formed with a plurality oftapered “petal” portions 504 that taper to a substantially rounded point606. In some embodiments, for example, there are four diametricallyopposed petal portions 604 that, when closed (FIG. 41), converge to forma relatively blunted pointed end 610. The petal portions 604 have anopen area 612 therebetween. In various embodiments, the petal portions604 are retained in the closed position by a releaseable retainer member620. In some embodiments for example, the retainer member comprisesshrink-wrap material 620 that is applied around the introducer 600. Insome embodiments, a plurality of retention ledges 630 may be formedaround the inner perimeter of the base 602 to engage the distal face 25of the stapling head 16 when the shrink wrap 620 has been applied.Release sutures 640 may be sewed through those portions 622 of theshrink-wrap 620 that cover the open area 612. The release sutures 640terminate in or are each attached to a release suture 650 that passesthrough a hole 652 in the base portion 602 and extends proximally out tothe handle portion of the stapler 10 to enable the release suture 650 tobe grasped by the clinician.

The introducer 600 may be installed by the supplier of the stapler 10 byshrink wrapping the introducer 600 to the stapling head 16. In use, theclinician inserts the stapler and introducer assembly 660 into thepatient's anus and past the Valves of Houston to the desired area. Oncethe clinician has determined that the stapling head of the stapler 10 isin the desired position, the clinician can then pull the release suture650 in the proximal direction “P” which causes the shrink-wrap 620 torupture thereby permitting the introducer 600 to be pulled distally overthe stapling head 16 as illustrated in FIG. 43.

FIGS. 44-46 illustrate another introducer 700 that may be used inconnection with a circular stapler 10. As can be seen in those Figures,the introducer 700 may be fabricated from, for example, polyurethaneblends, polyesters, polyethylene or polypropylene and have a baseportion 702 sized to be retained on the stapling head 16. The introducer700 is formed with a plurality of tapered “segment” portions 704 thattaper to a substantially rounded point 706. In some embodiments, forexample, there are four diametrically opposed segment portions 604 that,when closed (FIG. 44), converge to form a relatively blunted pointed end710. In the embodiment depicted in FIGS. 44-46, the introducer 700includes four segment portions 704. The segment portions 704 areinterconnected at their base portions except for two adjacent segmentportions 704 wherein the bases of the two segment portions 704 are notattached together. More particularly, segment portion 704A has a baseedge 705A and segment portion 704B has a base edge 705B. Edges 705A and705B are not attached to each other. Thus, segment portion 704A andsegment portion 704B comprise free ends of the base portion 702. Thefree ends 704A and 704B are retained in abutting relationship by aretainer member in the form of a radial release tab 720 that is attachedto 704A and 704B. In various embodiments, the release tab 720 is fixedor molded to segment portion 704A and may not necessarily be removedtherefrom. The release tab 720 is releaseably attached to segmentportion 704B. The release tab 720 may be attached to the segment portion704 by a releasable retainer 722 such as, for example, a releasableadhesive or piece of rupturable material. When the release tab 720 isattached as shown in FIG. 41, the segment portions 704 form an annularbase portion 702 that may be retainingly snapped onto or other wiseretainingly engage the stapling head 16 of the circular stapler 10. Arelease suture 730 is attached to the release tab 720 and extendsproximally out to the handle portion 12 of the stapler 10 to enable therelease suture 730 to be grasped by the clinician.

The introducer 700 may be snapped onto or pressed onto the stapling head16 by the clinician. In use, the clinician inserts the stapler andintroducer assembly 740 into the patient's anus and past the Valves ofHouston to the desired area. Once the clinician has determined that thestapling head 16 of the stapler 10 is in the desired position, theclinician can then pull the release suture 730 in the proximal direction“P” which causes the release tab 720 to release from the segment portion704B to enable the introducer 700 to release from the stapling head 16.Continued pulling on the release suture 730 will enable the introducer700 to be withdrawn from the patient.

Thus, the various embodiments of the circular stapler introducer of thepresent invention may facilitate the transanal and transabdominalinsertion and navigation to access the staple line of the distal stumpin lower anterior resections. The various introducers may be provided asa part of a kit that also includes a circular stapler 10. Variousembodiments of the introducer will have no impact on the currentfunctions of the circular stapler.

The various embodiments of the present invention represent a vastimprovement over prior circular staple arrangements that fail to provideany means for locking the anvil in a firing position. While severalembodiments of the invention have been described, it should be apparent,however, that various modifications, alterations and adaptations tothose embodiments may occur to persons skilled in the art with theattainment of some or all of the advantages of the invention. Forexample, according to various embodiments, a single component may bereplaced by multiple components, and multiple components may be replacedby a single component, to perform a given function or functions. Thisapplication is therefore intended to cover all such modifications,alterations and adaptations without departing from the scope and spiritof the disclosed invention as defined by the appended claims.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

The invention which is intended to be protected is not to be construedas limited to the particular embodiments disclosed. The embodiments aretherefore to be regarded as illustrative rather than restrictive.Variations and changes may be made by others without departing from thespirit of the present invention. Accordingly, it is expressly intendedthat all such equivalents, variations and changes which fall within thespirit and scope of the present invention as defined in the claims beembraced thereby.

1. An introducer for introducing a surgical circular stapler into apatient, the circular stapler having a handle portion, an elongatedshaft protruding from the handle portion, and a stapling head coupled tothe elongated shaft, said introducer comprising: a hollow flexiblesheath having a distal end and an open proximal end, said hollowflexible sheath sized to receive the stapling head and at least aportion of the elongated shaft therein; and a rigid cap assemblyattached to said distal end of said hollow flexible sheath, said rigidcap assembly configured to selectively move between a closed positionwherein a distal face of the stapling head is covered by said rigid capassembly when the stapling head has been inserted therein to a fullyinserted position and an open position wherein said cap assembly may beproximally withdrawn from around the stapling head and elongated shaft,said cap assembly having a portion shaped to match a shape of aperimeter of a corresponding portion of the stapling head to enable therigid cap assembly to pass proximally past the stapling head when beingwithdrawn therefrom.
 2. The introducer of claim 1 further comprising arelease arrangement interfacing with said rigid cap assembly toreleaseably retain said rigid cap assembly in said closed position. 3.The introducer of claim 1 wherein said rigid cap assembly comprises: abarrel member coupled to said distal end of said hollow flexible shaftand defining an opening sized to receive the stapling head therethrough;and a rigid cap member hingably attached to said barrel member and beingmovable between said closed position and said open position.
 4. Theintroducer of claim 3 wherein said rigid cap member has a substantiallysmooth distal surface.
 5. The introducer of claim 3 wherein said portionshaped to match a shape of a perimeter of a corresponding portion of thestapling head comprises an underside of said rigid cap member.
 6. Theintroducer of claim 5 wherein the stapling head has a circularperimetrical shape and wherein said underside of said rigid cap memberhas an arcuate shape that substantially matches a portion of saidcircular perimetrical shape of the stapling head.
 7. The introducer ofclaim 3 further comprising a release arrangement interfacing with saidbarrel member such that upon an application of a release motion thereto,said rigid cap member is movable to said open position.
 8. Theintroducer of claim 7 wherein said release arrangement comprises arelease latch in movable engagement with latch portions on said barrelmember.
 9. The introducer of claim 8 wherein said cap member is hingablyattached to said barrel member by a tether attached to said barrelmember in a position that is substantially diametrically opposite fromsaid latch portions on said barrel member.
 10. The introducer of claim 8wherein said cap member is hingably attached to said barrel member by atether attached to said barrel member in a position that is located at asubstantial right angle from said latch portions on said barrel member.11. The introducer of claim 3 wherein said cap member has across-sectional area that is larger than a cross-sectional area of thebarrel member.
 12. The introducer of claim 3 wherein said cap member ismore rigid than said barrel member.
 13. The introducer of claim 6further comprising a plurality of ribs formed in said underside of saidcap member.
 14. An introducer for introducing a surgical circularstapler into a patient, the circular stapler having a handle portion, anelongated shaft protruding from the handle portion, and a stapling headcoupled to the elongated shaft, said introducer comprising: a hollowflexible sheath having a distal end and an open proximal end, saidhollow flexible sheath sized to receive the stapling head and at least aportion of the elongated shaft therein; a radially-openable barrelmember attached to a distal end of said hollow flexible sheath anddefining an opening for receiving the stapling head therein, a latchmember in engagement with a pair of opposed ends of saidradially-openable barrel member, said latch member being selectivelymovable from a latched position engaging said opposed ends of saidbarrel member and an unlatched position wherein said opposed ends maymove radially away from each other; and a rigid cap member hingablyattached to said radially-openable barrel member and being movablebetween a closed position wherein said rigid cap member is retained in aclosed position covering a distal end of said opening in said barrelmember and an open position wherein said rigid cap member is movable toa position exposing said distal end of said opening in said barrelmember, said rigid cap member having an underside with a shape thatmatches a shape of a perimeter of a corresponding portion of thestapling head to enable said rigid cap member to pass proximally pastthe stapling head when being proximally withdrawn therefrom.
 15. Theintroducer of claim 14 wherein the stapling head has a circularperimetrical shape and wherein said underside of said cap member has anarcuate shape that substantially matches a portion of said circularperimetrical shape of the stapling head.
 16. The introducer of claim 14wherein said cap member is hingably attached to said barrel member by atether attached to said barrel member in a position that issubstantially diametrically opposite from said latch member.
 17. Theintroducer of claim 14 wherein said cap member is hingably attached tosaid barrel member by a tether attached to said barrel member in aposition that is located a substantial right angle from said latchmember.
 18. The introducer of claim 15 wherein said cap member has ablunt distal end surface that is substantially smooth.
 19. An introducerfor introducing a surgical circular stapler into a patient, the circularstapler having a handle portion, an elongated shaft protruding from thehandle portion, and a stapling head coupled to the elongated shaft, saidintroducer comprising: flexible means for removably encasing thestapling head and at least a portion of the elongated shaft of thecircular stapler; and end means for selectively presenting a rigid bluntsurface covering a distal face of the stapling head, said end means on adistal end of said means for removably encasing, and said end meanscomprising: means for selectively exposing the distal face of thestapling head; and means for presenting a surface configured to match aportion of a perimetrical shape of the stapling head when in an openposition to enable the end means to pass proximally past the staplinghead when being proximally withdrawn therefrom.
 20. The introducer ofclaim 19 wherein said flexible means comprises an open-ended sheathextending from said end means to the handle portion of the circularstapler when the stapling head and elongated shaft portion are fullyinserted therein.